E-health-supported Diagnostic and Intervention in Preterm Born Children and Their Families
NCT ID: NCT06939192
Last Updated: 2025-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-01-31
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Intervention Group (APP)
The participants in the intervention group will be equipped with an app after inclusion in the study. The app contains specific information for parents with premature babies, a contact form for experts and questions about the child's development every 14 days.
Intervention Group (APP)
Combination of app-based information and diagnostic screening for parents of premature babies.
Treatment as usual Group (TAU)
Participants in the treatment as usual group do not receive an app after inclusion in the study. They can contact their pediatrician if they have any questions.
Treatment as usual-Group (TAU)
No intervention. Treatment in the form of usual aftercare service is possible.
Interventions
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Intervention Group (APP)
Combination of app-based information and diagnostic screening for parents of premature babies.
Treatment as usual-Group (TAU)
No intervention. Treatment in the form of usual aftercare service is possible.
Eligibility Criteria
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Inclusion Criteria
* Gestational age 28-34 weeks,
* Mother: age ≥ 18 years,
* agreement to participate in this study and signing of a consent form,
* sufficient knowledge of German,
* internet access
Exclusion Criteria
* at least one of the children has serious diseases of the nervous system or obvious symptoms of a nervous disease,
* at least one of the children has serious congenital diseases or suffers from malformations,
* Mother: Lack of access to a smartphone/tablet,
* no internet access,
* insufficient knowledge of German
28 Weeks
34 Weeks
ALL
Yes
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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PD Dr. Annette Conzelmann
Prof. Dr. Annette Conzelmann
Principal Investigators
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Annette Conzelmann, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen
Annika K Alt
Role: STUDY_CHAIR
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen
Tobias J Renner, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen
Axel Franz, Prof. Dr.
Role: STUDY_CHAIR
Neonatology, University of Tübingen
Mirja Quante, Dr.
Role: STUDY_CHAIR
Neonatology, University of Tübingen
Michaela Minarski, Dr.
Role: STUDY_CHAIR
Neonatology, University of Tübingen
Johanna Löchner, Prof. Dr.
Role: STUDY_CHAIR
Clinical Psychology, FAU Erlangen
Locations
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University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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652/2023BO2
Identifier Type: -
Identifier Source: org_study_id
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